Featured Presentations include:
-- Assessing Benefit-Risk Assessment as a Guidepost for Developing Risk Management
Plans and REMS
Paul Coplan, D.Sc., MBA, Executive Director, Risk Management and Epidemiology,
Purdue Pharma L.P.
-- Qualitative Strategies towards Benefits Optimization, Risk Minimization and Uncertainties
Robyn Lim, Ph.D., Scientific Advisor, Office of Legislative and Regulatory Modernization,
Health Products and Food Branch, Health Canada
-- FDA Drug Safety Oversight Board and its Role in the Evaluation of, and Communication
About, Important Post-market Drug Safety Issues
Steve Osborne, M.D., Executive Director, Drug Safety Oversight Board, CDER, FDA
-- Registries and Observational Studies: Analyzing and Incorporating Drug/Condition
Information for Overall Population and Subgroups to Demonstrate your Product's True
Value and Risk/Benefit and Improve Decision Making
John Parkinson, Ph.D., Director, GPRD, Medicines & Healthcare Products Regulatory
This conference is co-located with the inaugural Mitigating Safety Risks in Early Clinical Development conference.
Advance registration discounts for both drug safety forums are available until September 17, 2010. For complete event details, visit http://www.healthtech.com/
To apply for a press pass, please email Tracey Fielding, firstname.lastname@example.org.
To inquire about partnering or sponsoring, please contact Arnold Wolfson, email@example.com
This conference is sponsored by Clinquest, DDN, Drug Safety Alliance, Drug Safety Executive Council (DSEC), and United BioSource Corporation.
About Cambridge Healthtech Institute
Cambridge Healthtech Institute (CHI) is the preeminent life science network for leading researchers and business experts from top pharmaceutical, biotech and academic organizations. CHI’s portfolio of products includes Cambridge Healthtech Institute Conferences, Insight Pharma Reports, Barnett International, Cambridge Marketing Consultants, Cambridge Meeting Planners and Cambridge Healthtech’s Media Group, which includes numerous e-newsletters as well as Bio-IT World magazine.
Founded in 1992, Cambridge Healthtech Institute strives to develop quality information sources that provide valuable new insights and competing points of view while offering balanced coverage of the latest developments. Basic research related to commercial implications is covered, with heavy emphasis placed on end-user insights into new products and technology as well as coverage on the strategy behind the business. www.chicorporate.com
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